A Study of Once-daily Oral ASC30 to Evaluate the Efficacy and Safety in Adult Participants With Obesity or Overweight With Type 2 Diabetes
About this study
Study ASC30-302 (AURORA-2) is a Phase III, global, multicenter, randomized, double-blind, placebo-controlled study to investigate the long-term efficacy, safety, and tolerability of three maintenance doses of once-daily oral ASC30 compared with placebo in participants with obesity or overweight and T2DM.
- Condition
- Obesity, Overweight, Chronic Weight Management, Type 2 Diabetes Mellitus
- Tested
- ASC30 tablets A1, Placebo
- Sponsor
- Ascletis Pharma (China) Co., Limited
Who can join
- Age
- 18 years and older
- Sex
- All sexes
- Healthy volunteers
- Not accepted
Inclusion 6
- Minimum age: 18 years
- Study condition: Obesity, Overweight, Chronic Weight Management, Type 2 Diabetes Mellitus
- Participant must be ≥18 years of age inclusive, or the legal age of consent in the jurisdiction in which the study is taking place at screening.
- Have a BMI ≥ 27 kg/m2 at screening.
- Have a history of at least 1 self-reported unsuccessful dietary effort to lose body weight.
- Have a diagnosis of T2D according to the WHO classification or other locally applicable standards, with HbA1c \> 6.5% (48 mmol/mol) to ≤10.5% (91 mmol/mol) at screening.
Exclusion 7
- Have Type 1 Diabetes Mellitus (T1DM), history of ketoacidosis or hyperosmolar state/coma, or any other types of diabetes except T2DM.
- Have a self-reported change in body weight \>5 kg (11 pounds) within 3 months prior to screening.
- Have an estimated glomerular filtration rate (eGFR) \< 15 mL/min/1.73 m2, as determined by the laboratory at screening.
- Have a history of acute or chronic pancreatitis any time prior to screening.
- Have known allergies or intolerance to glucagon-like peptide-1 Receptor Agonists (GLP-1 RA).
- Participants with a personal or family (first-degree relative) history of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia (MEN) syndrome type 2.
- Are currently enrolled in any other clinical study involving an investigational product or any other type of medical research judged not to be scientifically or medically compatible with this study at the investigator's discretion.
Where
135 sites, 135 recruiting
AURORA-2 Clinical Site
Austin, Texas, United States
AURORA-2 Clinical Site
Evansville, Indiana, United States
AURORA-2 Clinical Site
Melbourne, Florida, United States
AURORA-2 Clinical Site
Phoenix, Arizona, United States
AURORA-2 Clinical Site
San Antonio, Texas, United States
AURORA-2 Clinical Site
The Villages, Florida, United States
and 129 more sites on ClinicalTrials.gov
Potential match only. Final eligibility is determined by the study team.